Argus Safety Database jobs

Patient Safety and Pharmacovigilance Specialist

WEP Clinical · Posted Jul 23, 2025

Remote, Canada
Remote
3+ years

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Responsible for executing International Adverse Event and pharmacovigilance activities, coordinating PV activities for sites worldwide, providing support, training, and oversight in related drug safety activities.

Responsibilities

Monitor the Pharmacovigilance (PV) System through development of monthly performance reports to ensure regulatory compliance and process effectiveness.
Prepare and analyze periodic PV metrics including KPIs, quality incidents, CAPAs, audits, and inspection outcomes.
Compile and trend compliance data, conduct root cause assessments, gap analyses, and evaluate effectiveness of corrective actions.
Evaluate safety reports and study documents for completeness, accuracy, and clinical relevance.
Support audit and inspection readiness, and assist during internal audits and health authority inspections.

Requirements

Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences discipline
Advanced degree (e.g., BPharm, PharmD, RN, MD, MSc, or equivalent)

Skills

Drug safety Pharmacovigilance Clinical Trials Drug development (phases 1-4)

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